Peanut Allergy
Conditions
Keywords
Characterized Peanut Allergen, Peanut, OIT, Oral Desensitization, Peanut Allergen, Peanut-Allergic Children, Children, Peanut-Allergic Adults
Brief summary
This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.
Detailed description
This phase 2, open-label, follow-on, multicenter study was designed to gather additional information on the safety, tolerability, and efficacy of oral desensitization with AR101 in subjects who participated in study ARC001 (NCT01987817) as follows: * Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001 * Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001 All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of Characterized Peanut Allergen (CPNA). Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may continue Extended Maintenance Phase until CPNA becomes commercially available or the study is terminated.
Interventions
BIOLOGICALAR101 - Peanut protein capsule
Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Sponsors
Aimmune Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 26 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Completion of ARC001 study * No change in the status of any longitudinally applicable ARC001 inclusion criteria Key
Exclusion criteria
* Early termination from ARC001 * Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge * A lapse in dosing of more than 10 days from completion of ARC001 * Change in the status of any longitudinally applicable ARC001
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Up to 90 weeks | TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. | Up to 60 weeks. | — |
| Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein | Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance) | The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population. |
| Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance) | The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs |
| Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance | Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks) | — |
| The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC | Up to 36 weeks | — |
| Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks) | — |
| Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | Up to 36 weeks for up-dosing | Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC |
| Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance) | Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC |
| Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. | Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks) | A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity. |
| Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance | Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ARC001 Placebo Group Subjects who received placebo in study ARC001.
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | 26 |
| ARC001 AR101 Group Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.
AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | 21 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Failure to tolerate | 2 | 0 |
| Overall Study | Not stated | 1 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 8 |
Baseline characteristics
| Characteristic | ARC001 Placebo Group | ARC001 AR101 Group | Total |
|---|---|---|---|
| Age, Continuous | 8.5 years | 8.0 years | 8.0 years |
| Age, Customized 18-26 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized 4-17 years | 26 Participants | 20 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 21 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 20 Participants | 18 Participants | 38 Participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 16 Participants | 14 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 21 |
| other Total, other adverse events | 26 / 26 | 21 / 21 |
| serious Total, serious adverse events | 0 / 26 | 1 / 21 |
Outcome results
Primary
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months
TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).
Time frame: Up to 90 weeks
Population: The Safety Population (those who received any amount of AR101)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ARC001 Placebo Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any TEAE | 26 Participants |
| ARC001 Placebo Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any TEAE Event Leading to Study Treatment Permanently Withdrawn | 4 Participants |
| ARC001 Placebo Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any TEAE Related to Study Treatment | 25 Participants |
| ARC001 Placebo Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any Treatment-Related Hypersensitivity Adverse Event | 5 Participants |
| ARC001 Placebo Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any Grade 3 or Higher TEAE | 1 Participants |
| ARC001 Placebo Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any TEAE Leading to Study Treatment Temporarily Withdrawn | 12 Participants |
| ARC001 Placebo Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any Serious TEAE leading to Death | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any serious TEAE | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any Serious TEAE leading to Death | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any TEAE | 21 Participants |
| ARC001 AR101 Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any Grade 3 or Higher TEAE | 1 Participants |
| ARC001 AR101 Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any TEAE Related to Study Treatment | 15 Participants |
| ARC001 AR101 Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any TEAE Leading to Study Treatment Temporarily Withdrawn | 15 Participants |
| ARC001 AR101 Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any TEAE Event Leading to Study Treatment Permanently Withdrawn | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any Treatment-Related Hypersensitivity Adverse Event | 4 Participants |
| ARC001 AR101 Group | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months | Any serious TEAE | 1 Participants |
Secondary
Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein
The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population.
Time frame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
Population: Only includes food challenge completer population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| ARC001 Placebo Group | Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein | AR101 baseline (mg) [2] | 38.90 mg | Standard Deviation 4.37 |
| ARC001 Placebo Group | Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein | Up-dosing DBPCFC | 501.2 mg | Standard Deviation 1.55 |
| ARC001 Placebo Group | Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein | Maintenance DBPCFC | 776.2 mg | Standard Deviation 1.41 |
| ARC001 AR101 Group | Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein | AR101 baseline (mg) [2] | NA mg | — |
| ARC001 AR101 Group | Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein | Up-dosing DBPCFC | 524.8 mg | Standard Deviation 1.32 |
| ARC001 AR101 Group | Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein | Maintenance DBPCFC | 758.6 mg | Standard Deviation 1.55 |
Secondary
Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance
Time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Population: The Safety Population (those who received any amount of AR101)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| ARC001 Placebo Group | Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance | Up-dosing: Peanut-specific IgE | 59.145 kU/L | Standard Deviation 2.9154 |
| ARC001 Placebo Group | Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance | Change from baseline: Peanut-specific IgE | 0.387 kU/L | Standard Deviation 2.2479 |
| ARC001 Placebo Group | Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance | Extended maintenance: Peanut-specific IgE | 14.880 kU/L | Standard Deviation 6.7531 |
| ARC001 Placebo Group | Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance | Change from up-dosing: Peanut-specific IgE | 0.364 kU/L | Standard Deviation 2.8292 |
| ARC001 Placebo Group | Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance | Baseline: Peanut-specific IgE | 56.826 kU/L | Standard Deviation 2.8864 |
| ARC001 AR101 Group | Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance | Change from up-dosing: Peanut-specific IgE | 0.228 kU/L | Standard Deviation 2.0544 |
| ARC001 AR101 Group | Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance | Baseline: Peanut-specific IgE | NA kU/L | — |
| ARC001 AR101 Group | Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance | Up-dosing: Peanut-specific IgE | 29.964 kU/L | Standard Deviation 4.4817 |
| ARC001 AR101 Group | Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance | Extended maintenance: Peanut-specific IgE | 10.381 kU/L | Standard Deviation 4.0149 |
| ARC001 AR101 Group | Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance | Change from baseline: Peanut-specific IgE | NA kU/L | — |
Secondary
Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance
Time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Population: The Safety Population (those who received any amount of AR101)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| ARC001 Placebo Group | Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance | Up-dosing: Peanut-specific IgG4 | 3.004 μg/mL | Standard Deviation 3.8962 |
| ARC001 Placebo Group | Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance | Change from baseline: Peanut-specific IgG4 | 12.429 μg/mL | Standard Deviation 2.2705 |
| ARC001 Placebo Group | Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance | Extended maintenance: Peanut-specific IgG4 | 5.755 μg/mL | Standard Deviation 3.6328 |
| ARC001 Placebo Group | Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance | Change from up-dosing: Peanut-specific IgG4 | 1.682 μg/mL | Standard Deviation 3.1268 |
| ARC001 Placebo Group | Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance | Baseline: Peanut-specific IgG4 | 0.538 μg/mL | Standard Deviation 2.4351 |
| ARC001 AR101 Group | Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance | Change from up-dosing: Peanut-specific IgG4 | 2.746 μg/mL | Standard Deviation 3.4556 |
| ARC001 AR101 Group | Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance | Baseline: Peanut-specific IgG4 | NA μg/mL | — |
| ARC001 AR101 Group | Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance | Up-dosing: Peanut-specific IgG4 | 4.096 μg/mL | Standard Deviation 3.9749 |
| ARC001 AR101 Group | Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance | Extended maintenance: Peanut-specific IgG4 | 12.429 μg/mL | Standard Deviation 2.8292 |
| ARC001 AR101 Group | Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance | Change from baseline: Peanut-specific IgG4 | NA μg/mL | — |
Secondary
Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance.
A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity.
Time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Population: The Safety Population (those who received any amount of AR101)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARC001 Placebo Group | Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. | Up-dosing | 34.9 score on a scale | Standard Deviation 21.42 |
| ARC001 Placebo Group | Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. | Change from baseline | -26.30 score on a scale | Standard Deviation 34.5 |
| ARC001 Placebo Group | Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. | Extended maintenance | 27.5 score on a scale | Standard Deviation 25.03 |
| ARC001 Placebo Group | Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. | Change from up-dosing | -20.00 score on a scale | Standard Deviation 38.87 |
| ARC001 Placebo Group | Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. | Baseline | 36.4 score on a scale | Standard Deviation 24.31 |
| ARC001 AR101 Group | Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. | Change from up-dosing | -15.5 score on a scale | Standard Deviation 20.56 |
| ARC001 AR101 Group | Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. | Baseline | NA score on a scale | — |
| ARC001 AR101 Group | Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. | Up-dosing | 25.6 score on a scale | Standard Deviation 17.78 |
| ARC001 AR101 Group | Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. | Extended maintenance | 20.1 score on a scale | Standard Deviation 12.61 |
| ARC001 AR101 Group | Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. | Change from baseline | NA score on a scale | — |
Secondary
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance
Time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Population: The Safety Population (those who received any amount of AR101)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARC001 Placebo Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Peanut wheal diameter; baseline | 11.8 millimeter | Standard Deviation 6.29 |
| ARC001 Placebo Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Peanut wheal diameter; up-dosing | 8.6 millimeter | Standard Deviation 4.62 |
| ARC001 Placebo Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Peanut wheal diameter; extended maintenance | 9.0 millimeter | Standard Deviation 5.77 |
| ARC001 Placebo Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Change from baseline: Peanut wheal diameter | -1.5 millimeter | Standard Deviation 6.52 |
| ARC001 Placebo Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Change from up-dosing: Peanut wheal diameter | -0.8 millimeter | Standard Deviation 4.72 |
| ARC001 Placebo Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Peanut erythema/flare; baseline | 37.6 millimeter | Standard Deviation 17.69 |
| ARC001 Placebo Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Peanut erythema/flare; up-dosing | 26.8 millimeter | Standard Deviation 12.05 |
| ARC001 Placebo Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Peanut erythema/flare; extended maintenance | 28.2 millimeter | Standard Deviation 19.73 |
| ARC001 Placebo Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Change from baseline: peanut erythema/flare | -8.7 millimeter | Standard Deviation 15.35 |
| ARC001 Placebo Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Change from up-dosing: peanut erythema/flare | -1.8 millimeter | Standard Deviation 11.55 |
| ARC001 AR101 Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Peanut erythema/flare; extended maintenance | 14.7 millimeter | Standard Deviation 11.62 |
| ARC001 AR101 Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Peanut wheal diameter; baseline | NA millimeter | — |
| ARC001 AR101 Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Peanut erythema/flare; baseline | NA millimeter | — |
| ARC001 AR101 Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Peanut wheal diameter; up-dosing | 6.6 millimeter | Standard Deviation 3.04 |
| ARC001 AR101 Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Change from up-dosing: peanut erythema/flare | -5.4 millimeter | Standard Deviation 9.79 |
| ARC001 AR101 Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Peanut wheal diameter; extended maintenance | 5.1 millimeter | Standard Deviation 3.4 |
| ARC001 AR101 Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Peanut erythema/flare; up-dosing | 21.8 millimeter | Standard Deviation 8.76 |
| ARC001 AR101 Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Change from baseline: Peanut wheal diameter | NA millimeter | — |
| ARC001 AR101 Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Change from baseline: peanut erythema/flare | NA millimeter | — |
| ARC001 AR101 Group | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance | Change from up-dosing: Peanut wheal diameter | -0.7 millimeter | Standard Deviation 2.98 |
Secondary
Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated
The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs
Time frame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
Population: Only includes food challenge completer population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARC001 Placebo Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Up-dosing DBPCFC | 100 mg | 1 Participants |
| ARC001 Placebo Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Up-dosing DBPCFC | 300 mg | 3 Participants |
| ARC001 Placebo Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Up-dosing DBPCFC | 600 mg | 17 Participants |
| ARC001 Placebo Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Up-dosing DBPCFC | 1000 mg | NA Participants |
| ARC001 Placebo Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Maintenance DBPCFC | 100 mg | 0 Participants |
| ARC001 Placebo Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Maintenance DBPCFC | 300 mg | 1 Participants |
| ARC001 Placebo Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Maintenance DBPCFC | 600 mg | 8 Participants |
| ARC001 Placebo Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Maintenance DBPCFC | 1000 mg | 11 Participants |
| ARC001 AR101 Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Maintenance DBPCFC | 1000 mg | 13 Participants |
| ARC001 AR101 Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Up-dosing DBPCFC | 100 mg | 0 Participants |
| ARC001 AR101 Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Maintenance DBPCFC | 100 mg | 0 Participants |
| ARC001 AR101 Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Up-dosing DBPCFC | 300 mg | 4 Participants |
| ARC001 AR101 Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Maintenance DBPCFC | 600 mg | 4 Participants |
| ARC001 AR101 Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Up-dosing DBPCFC | 600 mg | 17 Participants |
| ARC001 AR101 Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Maintenance DBPCFC | 300 mg | 3 Participants |
| ARC001 AR101 Group | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated | Up-dosing DBPCFC | 1000 mg | NA Participants |
Secondary
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC
Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC
Time frame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
Population: Only subjects who completed the food challenge at each challenge dose during the Maintenance DBPCFC were analyzed
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 10 mg | Missing | 14 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 100 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 10 mg | None | 6 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 100 mg | Missing | 13 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 30 mg | None | 6 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 300 mg | None | 6 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 3 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 300 mg | Mild | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 30 mg | Mild | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 300 mg | Moderate | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 10 mg | Mild | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 300 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 30 mg | Moderate | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 300 mg | Missing | 14 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 3 mg | Moderate | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 600 mg | None | 7 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 30 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 600 mg | Mild | 2 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 10 mg | Moderate | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 600 mg | Moderate | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 30 mg | Missing | 14 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 600 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 3 mg | Missing | 13 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 600 mg | Missing | 11 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 100 mg | None | 6 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 1000 mg | None | 5 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 10 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 1000 mg | Mild | 7 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 100 mg | Mild | 1 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 1000 mg | Moderate | 2 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 3 mg | Mild | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 1000 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 100 mg | Moderate | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 1000 mg | Missing | 6 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 3 mg | None | 7 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 1000 mg | Missing | 6 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 3 mg | None | 9 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 3 mg | Mild | 1 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 3 mg | Moderate | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 3 mg | Severe | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 3 mg | Missing | 10 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 10 mg | None | 9 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 10 mg | Mild | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 10 mg | Moderate | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 10 mg | Severe | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 10 mg | Missing | 11 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 30 mg | None | 9 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 30 mg | Mild | 1 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 30 mg | Moderate | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 30 mg | Severe | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 30 mg | Missing | 10 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 100 mg | None | 9 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 100 mg | Mild | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 100 mg | Moderate | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 100 mg | Severe | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 100 mg | Missing | 11 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 300 mg | None | 8 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 300 mg | Mild | 1 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 300 mg | Moderate | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 300 mg | Severe | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 300 mg | Missing | 11 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 600 mg | None | 7 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 600 mg | Mild | 3 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 600 mg | Moderate | 1 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 600 mg | Severe | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 600 mg | Missing | 9 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 1000 mg | None | 7 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 1000 mg | Mild | 4 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 1000 mg | Moderate | 2 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC | 1000 mg | Severe | 1 Participants |
Secondary
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC
Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC
Time frame: Up to 36 weeks for up-dosing
Population: Only subjects who completed the food challenge at each challenge dose during the Up-dosing DBPCFC were analyzed
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 100 mg | None | 11 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 10 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 100 mg | Mild | 1 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 3 mg | Mild | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 100 mg | Moderate | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 10 mg | Missing | 10 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 100 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 10 mg | None | 10 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 100 mg | Missing | 9 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 30 mg | None | 10 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 300 mg | None | 7 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 3 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 300 mg | Mild | 4 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 30 mg | Mild | 2 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 300 mg | Moderate | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 10 mg | Mild | 1 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 300 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 30 mg | Moderate | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 300 mg | Missing | 10 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 3 mg | Moderate | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 600 mg | None | 6 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 30 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 600 mg | Mild | 6 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 10 mg | Moderate | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 600 mg | Moderate | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 30 mg | Missing | 9 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 600 mg | Severe | 0 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 3 mg | Missing | 10 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 600 mg | Missing | 9 Participants |
| ARC001 Placebo Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 3 mg | None | 11 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 600 mg | Missing | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 3 mg | None | 18 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 3 mg | Mild | 3 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 3 mg | Moderate | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 3 mg | Severe | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 3 mg | Missing | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 10 mg | None | 21 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 10 mg | Mild | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 10 mg | Moderate | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 10 mg | Severe | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 10 mg | Missing | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 30 mg | None | 20 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 30 mg | Mild | 1 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 30 mg | Moderate | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 30 mg | Severe | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 30 mg | Missing | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 100 mg | None | 18 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 100 mg | Mild | 3 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 100 mg | Moderate | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 100 mg | Severe | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 100 mg | Missing | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 300 mg | None | 20 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 300 mg | Mild | 1 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 300 mg | Moderate | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 300 mg | Severe | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 300 mg | Missing | 0 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 600 mg | None | 12 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 600 mg | Mild | 5 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 600 mg | Moderate | 4 Participants |
| ARC001 AR101 Group | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC | 600 mg | Severe | 0 Participants |
Secondary
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.
Time frame: Up to 60 weeks.
Population: The Safety Population (those who received any amount of AR101). Multiple food challenge dose levels were given at each DBPCFC, so results at 300 mg and 600 mg for Maintenance DBPCFC are not expected to match those for Up-dosing DBPCFC.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ARC001 Placebo Group | The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. | Maintenance DBPCFC: Responder at 300 mg | 20 Participants |
| ARC001 Placebo Group | The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. | Maintenance DBPCC: Responder at 600 mg | 20 Participants |
| ARC001 Placebo Group | The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. | Maintenance DBPCC: Responder at 1000 mg | 17 Participants |
| ARC001 AR101 Group | The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. | Maintenance DBPCFC: Responder at 300 mg | 20 Participants |
| ARC001 AR101 Group | The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. | Maintenance DBPCC: Responder at 600 mg | 18 Participants |
| ARC001 AR101 Group | The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. | Maintenance DBPCC: Responder at 1000 mg | 14 Participants |
Secondary
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC
Time frame: Up to 36 weeks
Population: The Safety Population (those who received any amount of AR101). Only results for the ARC001 AR101 Group is reported as only subjects in this group had Up-dosing DBPCFC in ARC002 study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ARC001 Placebo Group | The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC | Up-dosing DBPCFC: Responder at 300 mg | 20 Participants |
| ARC001 Placebo Group | The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC | Up-dosing DBPCFC: Responder at 600 mg | 19 Participants |